A Houston-led study has found that the world’s first heart pump for babies and small children provides a life-saving bridge to transplantation, heralding a new era of care for pediatric heart disease patients.
Decades after heart pumps began extending the lives of adult cardiac patients, the study led by Texas Children’s Hospital showed the miniature device known as the Berlin Heart kept 90 percent of children alive while they waited for a donor organ. Without the device, small children have little hope of surviving long once their hearts start failing.
“This shows children don’t have to be second-class citizens any longer,” said Dr. Charles Fraser Jr., surgeon-in-chief at Texas Children’s and the principal investigator of the study, which involved 17 children’s hospitals around the nation. “Doctors now should have confidence they can offer children the same kind of heart support adults have been getting.”
Fraser said the study, published in Wednesday’s New England Journal of Medicine, should “get the word out” about the artificial heart’s effectiveness. The device was approved by the U.S. Food and Drug
administration in December based on the trial.
Fraser, also a professor of surgery and pediatrics at Baylor College of Medicine, estimated that 200 to 300 children a year could benefit from the heart. Heart failure in children is rare, the reason a device’s development has lagged so far behind adult pumps, but a third of patients on the waiting list for a transplant die before one becomes available.
The pump, manufactured in Germany and available in sizes to fit children from newborns to teenagers, connects to the heart through a pair of tubes and is run by a laptop computer to help the heart’s ventricles pump blood to the lungs and body.
Fraser called the 90 percent survival rate “astonishing.” The trial is the first to follow patients from the device’s implantation at multiple hospitals to their outcome, instead of just looking back at how children on the device fared.
The study did find a higher-than-anticipated rate of stroke associated with the device — 30 percent — though Fraser said the children all recovered without any neurological impairment. It also found significant amounts of bleeding and infection, both easily controlled.
The Berlin Heart was been approved in Europe since 1992. It has been implanted in roughly 1,000 children worldwide.